Delcath Systems, Inc. a specialty pharmaceutical and device company with a primary focus on developing treatments for primary and metastatic liver cancer recently announced the publication of their Phase 3 study findings in a top peer-reviewed journal.
The study, which completed enrollment in 2009, used the company’s leading proprietary product Melphalan Hydrochloride Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS), which is designed to administer high dose chemotherapy to the liver while controlling the systemic exposure to those agents in patients with melanoma with liver metastases.
The study reporting the results is titled “A Random-Assignment Study of Hepatic Arterial Infusion of Melphalan with Venous Filtration via Peripheral (Percutaneous) Hepatic Perfusion (PHP) (Delcath System) versus Best Alternative Care for Ocular and Cutaneous Melanoma Metastatic to the Liver” published in Springer’s ADIS journal, and was organized and proposed for submission by the senior author and leading researcher James F. Pingpank, Jr., M.D., and Associate Professor of Surgery at the University of Pittsburgh Medical Center, and by the first author Marybeth S. Hughes, M.D., at the Center for Cancer Research, National Cancer Institute, on behalf of the researchers who took part in the Phase 3 trial.
“The submission of this manuscript is a key milestone for Delcath and we are optimistic that the manuscript will be accepted for publication in a peer-reviewed journal. We believe that future publication will be an important tool in support of our efforts to obtain reimbursement in a number of European countries and will also help increase awareness of the value of this therapy,” stated Jennifer Simpson, Ph.D., MSN, CRNP, Interim President and Chief Executive Officer of Delcath in a recent news release.
The Melphalan/HDS technology is a combination drug and device product, and is regulated as a drug by the United States Food and Drug Administration (FDA), however, it had not received approval for sale. In Europe the system is commercialized under the name of Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT).
Delcath Systems, Inc. obtained in April 2012, permission to affix a CE Mark for the Generation Two CHEMOSAT system. The right to affix the CE mark allows the Company to market and sell the CHEMOSAT system in Europe. The Company has begun a global phase 2 clinical trial in Europe to examine Melphalan/HDS system for primary liver cancer and is initiating plans to assess intrahepatic cholangiocarcinoma.